Regulation and official guidance Archives

Organisation: Department for Science, Innovation and Technology; Foreign, Commonwealth & Development Office; Prime Minister's Office, 10 Downing Street

Last Updated: 29 Feb 2024

Regulation and official guidance

Introduction to AI assurance

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Domain:

Horizontal

“The Introduction to AI assurance provides a grounding in AI assurance for readers who are unfamiliar with the subject area.…

Organisation: Department for Science, Innovation and Technology; Foreign, Commonwealth & Development Office; Prime Minister's Office, 10 Downing Street

Last Updated: 29 Feb 2024

Regulation and official guidance

Clinical decision support software: Guidance for industry and Food and Drug Administration staff

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Topic:

Bias Data collection

Domain:

Healthcare and medicine

Organisation: U.S. Food and Drug Administration

Last Updated: 23 Jan 2024

Regulation and official guidance

How to use AI and personal data appropriately and lawfully

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Topic:

Bias and discrimination Explainability and transparency Risk management Safety

Domain:

Horizontal

Increasingly, we are seeing an uptake in applications of artificial intelligence (AI). The use of AI has the potential to…

Organisation: Information Commissioner's Office

Last Updated: 23 Jan 2024

Regulation and official guidance

Guidance on GxP data integrity

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Topic:

Data

Domain:

Healthcare and medicine

The guidance is intended to be a useful resource on the core elements of a compliant data governance system across…

Organisation: Medicines and Healthcare products Regulatory Agency

Last Updated: 23 Jan 2024

Regulation and official guidance

Software and artificial intelligence (AI) as a medical device

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Topic:

Safety

Domain:

Healthcare and medicine - Medical devices

Software (including AI) plays an essential part in health and social care. In the UK, many of these products are…

Organisation: Medicines and Healthcare products Regulatory Agency

Last Updated: 23 Jan 2024

Regulation and official guidance

Guidance for manufacturers on reporting adverse incidents involving Software as a Medical Device under the vigilance system

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Topic:

Safety Trustworthy AI

Domain:

Healthcare and medicine - Medical devices

Any event which meets the three reporting criteria (MEDDEV 2.12/1 rev 8, 5.1.1) is considered an adverse incident and must…

Organisation: Medicine & Healthcare products Regulatory Authority

Last Updated: 30 May 2023

Regulation and official guidance

Artificial intelligence in public services

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Topic:

Bias and discrimination Ethical considerations Good practice for development and use Human rights

Domain:

Public sector

Last Updated: 12 Oct 2022

Regulation and official guidance

Guidance: medical device stand-alone software including apps

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Topic:

Good practice for development and use Safety

Domain:

Healthcare and medicine - Medical devices

Information on when software applications are considered to be a medical device and how they are regulated. This content is…

Last Updated: 12 Oct 2022

Regulation and official guidance

Digital technology assessment criteria (DTAC)

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Topic:

Assurance and testing Data protection Procurement Safety Security and resilience

Domain:

Healthcare and medicine - Medical devices

The Digital Technology Assessment Criteria for health and social care (DTAC) gives staff, patients and citizens confidence that the digital…

Last Updated: 12 Oct 2022

Content Type

Guidelines for secure AI system development

Generative AI framework for HMG

Implementing the UK’s AI regulatory principles: Initial guidance for regulators

Introduction to AI assurance

Clinical decision support software: Guidance for industry and Food and Drug Administration staff

How to use AI and personal data appropriately and lawfully

Guidance on GxP data integrity

Software and artificial intelligence (AI) as a medical device

Guidance for manufacturers on reporting adverse incidents involving Software as a Medical Device under the vigilance system

Artificial intelligence in public services

Guidance: medical device stand-alone software including apps

Digital technology assessment criteria (DTAC)

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